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A Crossover Study in the Treatment of Patients With COPD
This study has been completed.

First Received on April 17, 2007.   Last Updated on March 3, 2009   History of Changes
Sponsor: Dey
Information provided by: Dey
ClinicalTrials.gov Identifier: NCT00462540
  Purpose

The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Formoterol Fumurate inhalation solution 20 mcg
Drug: Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Albuterol Ipratropium bromide Formoterol fumarate Levalbuterol hydrochloride Albuterol sulfate Ipratropium Arformoterol Formoterol Arformoterol Tartrate Levalbuterol tartrate
U.S. FDA Resources

Further study details as provided by Dey:

Primary Outcome Measures:
  • Lung function after 2 weeks of treatment

Secondary Outcome Measures:
  • Lung function at each time point, patient questionnaires, medication compliance,
  • adverse events, clinical labs, vital signs, ECGs, physical exams

Estimated Enrollment: 100
Study Start Date: May 2007
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
  • Meet lung function requirements

Exclusion Criteria:

  • Diagnosis of Asthma
  • Significant disease other than COPD
  • Female pregnant or lactating or planning to become pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462540

Locations
United States, California
Research Site
San Diego, California, United States, 92120
United States, Colorado
Research Site
Denver, Colorado, United States, 80206
Research Site
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Research Site
Panama City, Florida, United States, 32405
Research Site
Pensacola, Florida, United States, 32504
United States, Idaho
Research Site
Coeur d'Alene, Idaho, United States, 83814
United States, Louisiana
Research Site
Sunset, Louisiana, United States, 70584
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
United States, Oregon
Research Site
Portland, Oregon, United States, 97213
United States, South Carolina
Research Site
Gaffney, South Carolina, United States, 29340
Research Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Research Site
Johnson City, Tennessee, United States, 37601
United States, Texas
Research Site
San Antonio, Texas, United States, 78205
United States, Washington
Research Site
Spokane, Washington, United States, 99204
United States, West Virginia
Research Site
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Dey
  More Information

Publications:
Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI *. Curr Med Res Opin. 2009 Mar;25(3):653-61.

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00462540     History of Changes
Other Study ID Numbers: 201-081
Study First Received: April 17, 2007
Last Updated: March 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
COPD
Formoterol
Ipratropium
Crossover

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Formoterol
Ipratropium
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
 Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012



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